---
title: "Early-warning Intervention for Heat and Cold in Older Hypertensive Patients: Impact on Blood Pressure and ECG"
nct_id: NCT06011213
overall_status: COMPLETED
phase: NA
sponsor: Tiantian Li
study_type: INTERVENTIONAL
primary_condition: Hypertension
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT06011213.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT06011213"
ct_last_update_post_date: 2025-01-24
last_seen_at: "2026-05-12T06:08:19.685Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# Early-warning Intervention for Heat and Cold in Older Hypertensive Patients: Impact on Blood Pressure and ECG

**Official Title:** Early-warning Intervention for Heat and Cold in Older Hypertensive Patients: Impact on Blood Pressure and Electrocardiogram

**NCT ID:** [NCT06011213](https://clinicaltrials.gov/study/NCT06011213)

## Key Facts

- **Status:** COMPLETED
- **Phase:** NA
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 342
- **Lead Sponsor:** Tiantian Li
- **Conditions:** Hypertension
- **Start Date:** 2023-07-01
- **Completion Date:** 2024-02-28
- **CT.gov Last Update:** 2025-01-24

## Brief Summary

This cluster-randomized trial, conducted in Tianjin, China, aims to evaluate the effectiveness of integrating a digital health risk early warning tool for heat with self-monitoring. Additionally, the study assesses the effectiveness of combining a digital health risk early warning tool for cold with self-monitoring. Communities from three districts will be randomly assigned to one of three groups: the combined intervention group (receiving health warnings via a WeChat mini-program and self-monitoring), the self-monitoring group (daily blood pressure (BP) and electrocardiogram (ECG) monitoring without warnings), and the control group (BP and ECG monitoring only during baseline and routine check-ups). The primary objective of the study is to evaluate the effectiveness of the intervention in improving blood pressure control and reducing the risk of electrocardiogram abnormalities, as well as understanding its underlying biological mechanisms.

## Detailed Description

This cluster-randomized trial will be conducted in various districts across Tianjin, China. As part of the early warning interventions for heat and cold, three communities from each of the two selected districts will be randomly chosen and assigned to one of three groups: the combined intervention group, the self-monitoring group, or the control group. The study will be divided into pre-intervention and intervention phases. The pre-intervention period for the heat wave health early-warning information intervention spans from July 1st, 2023, to July 7th, 2023, followed by the intervention period from July 8th to September 9th, 2023. Similarly, during the cold spell health early-warning information intervention, the pre-intervention phase occurs from December 1st, 2023, to December 7th, 2023, and the intervention.

Participants in the combined intervention group will receive heat health risk warnings via digital tools, specifically a WeChat mini-program, providing real-time updates on early warnings and health advisories. Additionally, they will be instructed to perform daily self-monitoring of their blood pressure (BP) and electrocardiogram (ECG) using automated home devices. Participants in the self-monitoring alone group will engage in daily BP and ECG monitoring but not receive any health warnings. In contrast, the control group will monitor their BP and ECG only during baseline assessments and routine health check-ups (the day after the first heat wave in July and August 2023, as well as following the first cold spell in January and February 2024).

All participants will be required to record their daily time-activity patterns. During the baseline and subsequent check-ups, data will be collected on participants' demographics, medical history, lifestyle factors (e.g., diet, smoking, physical activity), environmental exposures, sleep quality, mental health status (including stress levels, emotional stability, and psychological resilience), medication adherence, cardiovascular and cerebrovascular symptoms, respiratory system symptoms, and perceptions of heatwaves and cold spells. In addition, blood, urine, and stool samples will be gathered for further analysis.

## Eligibility

- **Minimum age:** 60 Years
- **Maximum age:** 65 Years
- **Sex:** ALL
- **Healthy Volunteers:** Yes

```
Inclusion Criteria:

Individuals aged 60 to 65 years Individuals with a diagnosis of hypertension Individuals with untreated blood pressure above 140/90 mm Hg

Exclusion Criteria:

Having a history of coronary heart disease, heart failure, or stroke Unable to cooperate with follow-up
```

## Arms

- **Combined intervention** (EXPERIMENTAL) — Participants in the combined intervention group will receive real-time health risk warnings for heat waves and cold spells via a WeChat mini-program and will perform daily self-monitoring of BP and ECG using automated home devices.
- **Self-monitoring alone** (OTHER)
- **Control** (NO_INTERVENTION)

## Interventions

- **Issuing health risk warning for a heat waves or cold spells** (BEHAVIORAL) — Whenever a health risk warning for a heat waves or cold spells is issued, only the elderly in the combined intervention group will be alerted to the early warning information through the digital heat or cold health risk early warning tool.
- **A digital heat or cold health risk early warning tool** (DEVICE) — A WeChat mini-program provides real-time updates on early warnings and health advisories.
- **Self-monitoring blood pressure and ECG device** (DEVICE) — Devices for self-monitoring blood pressure and ECG
- **Perform daily self-monitoring of their BP and ECG** (BEHAVIORAL) — Participants in the self-monitoring alone group were instructed to self-measure their BP three times each morning (from 6:00 a.m. to 8:00 a.m.) and evening (from 6:00 p.m. to 8:00 p.m.) at home, and to self-administer ECG measurements twice during the same morning and evening timeframes.

## Primary Outcomes

- **Change from baseline in DBP** _(time frame: baseline, six months)_ — The DBP was measured by a self-monitored electronic sphygmomanometer (Model Maibobo, Shenzhen Yike Network Technology Co., Ltd., China).
- **Change from baseline in SBP** _(time frame: baseline, six months)_ — The SBP was measured by a self-monitored electronic sphygmomanometer (Model Maibobo, Shenzhen Yike Network Technology Co., Ltd., China).
- **Change from baseline in the risk of the overall warning level for abnormal ECG.** _(time frame: baseline, six months)_ — Overall warning level for abnormal ECG is measured by a handheld electrocardiographic recorder, CarePatch (ECG-H01, Hangzhou Proton Technology Co., Ltd., China). This device is employed to assess and report on the presence of abnormal ECG states.

## Secondary Outcomes

- **Change from baseline in the control rate of blood pressure (SBP/DBP <120/80 mm Hg)** _(time frame: baseline, six months)_
- **Change from baseline in the control rate of blood pressure (SBP/DBP <140/90 mm Hg)** _(time frame: baseline, six months)_
- **Change from baseline in left ventricular hypertrophy** _(time frame: baseline, six months)_
- **Change from baseline in sinus arrhythmia** _(time frame: baseline, six months)_
- **Change from baseline in right bundle branch block** _(time frame: baseline, six months)_
- **Change from baseline in ventricular premature beats** _(time frame: baseline, six months)_
- **Change from baseline in atrial premature beats** _(time frame: baseline, six months)_
- **Change from baseline in Q waves** _(time frame: baseline, six months)_
- **Change from baseline in T-wave changes** _(time frame: baseline, six months)_
- **Change from baseline in ST changes** _(time frame: baseline, six months)_
- **Change from baseline in the heat wave and cold spell perception score** _(time frame: baseline, six months)_
- **Change from baseline in the PSQI score** _(time frame: baseline, six months)_
- **Change from baseline in the PHQ-9 score** _(time frame: baseline, six months)_
- **Change from baseline in the MMSE score** _(time frame: baseline, six months)_
- **Change from baseline in the GAD-7 score** _(time frame: baseline, six months)_
- **Change from baseline in the PSSS score** _(time frame: baseline, six months)_
- **Change from baseline in time-activity patterns** _(time frame: baseline, six months)_
- **Change from baseline in HPSMBRS score** _(time frame: baseline, six months)_
- **Change from baseline in HPMARS score** _(time frame: baseline, six months)_
- **Changes in liver function biomarkers (e.g., albumin (ALB), alanine aminotransferase (ALT), aspartate aminotransferase (AST), etc.) from baseline** _(time frame: baseline, six months)_
- **Changes in kidney function biomarkers (e.g., uric acid (UA), blood urea nitrogen (BUN), creatinine (CREA), etc.) from baseline** _(time frame: baseline, six months)_
- **Changes in cardiovascular biomarkers (e.g., creatine kinase-MB (CK-MB), creatine kinase (CK), etc.) from baseline** _(time frame: baseline, six months)_
- **Changes in inflammatory biomarkers (e.g., interleukin-6 (IL-6), interleukin-1β (IL-1β), etc.) from baseline** _(time frame: baseline, six months)_
- **Changes in metabolic biomarkers (e.g., lactate dehydrogenase (LDH), high-density lipoprotein (HDL), low-density lipoprotein cholesterol (LDL) , etc.) from baseline** _(time frame: baseline, six months)_

## Locations (1)

- National Institute of Environmental Health, Chinese Center for Disease Control and Prevention, Beijing, China

## Recent Field Changes (last 30 days)

- `locations.national institute of environmental health, chinese center for disease control and prevention|beijing||china` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_

---

*Canonical: https://parkinsonspathways.com/agent/trials/NCT06011213.md*  
*Source data (authoritative): https://clinicaltrials.gov/study/NCT06011213*  
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